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Wednesday, November 16, 2016

Data Integrity - two new documents from PIC/S and EMA

Image result for pic/s logoImage result for data integrity
Data Integrity - two new documents from PIC/S and EMA

PIC/S 041-1 "Good Practices for Data Management and Integrity in regulated GMP/GDP environments"
The current PIC/S draft document PI 041-1 contains 41 pages of detailed information. The document was written to provide guidance for inspectorates. The comment period for PIC/S Participating Authorities will end on 28 February 2017. The following activities have not been defined yet.
The introduction referred to the fact that the effectiveness of inspection processes is determined by the veracity of the evidence provided to the inspector and ultimately the integrity of the underlying data. Furthermore it is critical to the inspection process that inspectors can determine and, fully rely on the accuracy and completeness of evidence and records presented to them. Therefore Good Data Management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable.
The first third of the document introduces 3 basic principles:
  • Data governance system 
  • Organisational influences on successful data integrity management
  • General data integrity principles and enablers
The main part of the document focuses on the topics "Specific DI considerations for paper-based systems" and "Specific data integrity considerations for computerised systems". Here you can find the expectations of inspectors for different items. Each item will discussed in relation to "potential risk of not meeting expectations / items to be checked".
At the end of the document you will find 4 additional chapters on
  • Data integrity considerations for outsourced activities
  • Regulatory actions in response to data integrity findings
  • Remediation of data integrity failures
  • Definitions



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